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Title:
Automation Engineer
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Job Type:

Automation Engineer

Automation Engineer

GerTEK Project Management & Technical Services is one of Ireland’s leading Project Management and Technical Service companies. Due to continued expansion, we are hiring for an experienced Automation Engineer to join our team.

Job Responsibilities

  • Provide technical expertise for the design, configuration, installation, and maintenance of automation software and associated hardware; including interacting with other teams as necessary.
  • Oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant SCADA and BMS systems, data concentration, batch reporting, and data retention.
  • Prepare scopes of work and lead automation resources as required to complete work within the project timelines.
  • Develop equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
  • Take programs from concept through execution while managing all stages in the process utilizing a strong set of project management tools.
  • Maintain procedures to meet GMP requirements, CFR’s, and internal company policies.
  • Lead or contribute to programs supporting process commercialization of new products to ensure a smooth transition from development to GMP manufacturing.
  • Participate in operational excellence and continuous improvement efforts.
  • Partner with Quality to ensure a quality and compliant manufacturing environment.
  • Solve technical issues impacting production.
  • Support 24×7 site-based operations.
  • Create and update procedures to drive operational efficiency and compliance.
  • Implement and revise SOPs to conform to the highest industry standards and company policies.
  • Deploy, maintain, and upgrade manufacturing applications.
  • Perform investigations of non-conformances related to automation systems.
  • Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations.
  • Execute change controls to update and upgrade automation systems and equipment.
  • Other related duties as assigned.

Qualifications

  • B.S. degree in Engineering, Computer Science, or related technical field, or related technical field, with 5 years’ work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or 9 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
  • 5 years of experience in cell culture, recovery, purification, aseptic fill/finish

Key Requirements

  • Experience programming, troubleshooting, and maintaining site SCADA/HMI systems (e.g. FactoryTalk View SE, iFix, Wonderware, Emerson/DeltaV).
  • Experience programming, troubleshooting, and maintaining site PLC/BMS systems (e.g. ControlLogix, Siemens TIA/S7).
  • Experience programming, troubleshooting, and maintaining site data historian (e.g. FactoryTalk Historian).
  • Experience in authoring and executing test protocols for automation system level commissioning and qualification.
  • Proven experience applying S88 in an automated environment.
  • Working knowledge of the field device signal wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation.
  • Knowledge of industrial communication protocols such as MODBUS, Ethernet IP, etc.
  • Experience writing and executing change controls in change management systems.
  • Able to develop MS SQL queries.
  • Knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
  • Knowledge of Quality by Design, six-sigma, LEAN, and operational excellence tools in creating efficient and quality-driven processes and end products.
  • Excellent oral and written communication skills.
  • Strong project management skillset.
  • Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
  • Experience providing technical support on manufacturing issues and able to drive toward issue resolution

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